Facilitating your medical device certification

Surpassing medical ISO standards

Our medical gas equipment meets all requirements in safety and operating criteria. We design our products not only to comply with ISO certification. You know you will not compromise on quality, reliability or performance, because we surpass the strictest medical standards and regulations:

Medical Devices Directive MDD 93/42/EEC

European pharmacopeia

EN ISO 7396-1

ISO 14971

Health Technical Memorandums HTM 02-01 and HTM 2022

Our PDp dry dust filters have been thoroughly tested and certified by an external laboratory, proving they can serve as bacterial filters.